Label: BUSPIRONE HYDROCHLORIDE tablet

  • NDC Code(s): 69584-091-10, 69584-091-50, 69584-092-10, 69584-092-50, view more
  • Packager: Oxford Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 5, 2024

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  • SPL UNCLASSIFIED SECTION
    Buspirone Hydrochloride Tablets USP - (Patient Information Sheet Included) Rx only
  • DESCRIPTION
    Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs ...
  • CLINICAL PHARMACOLOGY
    The mechanism of action of buspirone is unknown. Buspirone differs from typical benzodiazepine anxiolytics in that it does not exert anticonvulsant or muscle relaxant effects. It also lacks the ...
  • INDICATIONS AND USAGE
    Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of ...
  • CONTRAINDICATIONS
    Buspirone hydrochloride tablets, USP are contraindicated in patients hypersensitive to buspirone hydrochloride. The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with ...
  • WARNINGS
    The administration of buspirone hydrochloride tablets, USP to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood ...
  • PRECAUTIONSGeneral
    Interference with Cognitive and Motor Performance - Studies indicate that buspirone hydrochloride tablets, USP are less sedating than other anxiolytics and that it does not produce ...
  • ADVERSE REACTIONS
    ADVERSE REACTIONS (See also PRECAUTIONS) Commonly Observed - The more commonly observed untoward events associated with the use of buspirone hydrochloride tablets, USP not seen at an ...
  • DRUG ABUSE AND DEPENDENCE
    Controlled Substance Class - Buspirone hydrochloride, USP is not a controlled substance. Physical and Psychological Dependence - In human and animal studies, buspirone has shown no ...
  • OVERDOSAGE
    Signs and Symptoms - In clinical pharmacology trials, doses as high as 375 mg/day were administered to healthy male volunteers. As this dose was approached, the following symptoms were ...
  • DOSAGE AND ADMINISTRATION
    The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The ...
  • HOW SUPPLIED:
    Buspirone Hydrochloride Tablets, USP 5 mg are white to off-white, round, flat-faced, beveled edge bisected tablets debossed “091” above the bisect on one side and "O" logo on the other side ...
  • REFERENCE
    American Psychiatric Association, Ed.:  Diagnostic and Statistical Manual of Mental Disorders—III, American Psychiatric Association, May 1980. Synthroid® is the registered trademark of Abbott ...
  • PATIENT PACKAGE INSERT
    Manufactured by:  Oxford Pharmaceuticals LLC - 301 Leaf Lake Parkway, Birmingham, AL 35211 USA - 8200016 - 02/22 - R02
  • Principal Display Panel
    NDC 69584-091-10 - BusPIRone - Hydrochloride - Tablets, USP - 5 mg - Rx only - 100 TABLETS - EACH TABLET CONTAINS: Buspirone Hydrochloride, USP...5mg - USUAL DOSAGE: See package insert - for ...
  • INGREDIENTS AND APPEARANCE
    Product Information